FDA Says No — At Least for Now — to Arena’s Weight-Loss Pill – lorcaserin

Arena Pharmaceuticals said early Saturday morning that the FDA won’t approve the company’s weight-loss drug lorcaserin without further data to support the drug’s efficacy and safety.

That wasn’t a terribly big surprise, given that an outside FDA advisory panel last month voted not to recommend approval. The FDA has questions about the possibility of a higher incidence of tumors in rats dosed with the drug, Arena said in a press release. And the agency wants to see data on how well the drug works in diabetic patients. “We will work with the FDA to address the issues with our [application] as soon as possible,” Arena President and CEO Jack Lief said in a statement.

But as the WSJ reports, satisfying the FDA may take more clinical trials, and those take time and money. The WSJ also reports that the company’s development partner for lorcaserin, Japan’s Eisai, said it “remains committed to working with Arena” but didn’t elaborate on what its options for the partnership are from here on out.

Meantime, the FDA is due to issue a decision on another weight-loss drug — Qnexa, made by Vivus — later this week. In July, an FDA advisory panel voted not to recommend approval of the drug, citing a need for longer-term data to assuage safety concerns. Yet another experimental diet drug, Orexigen’s Contrave, is scheduled for consideration by the panel on Dec. 7, with a decision due by the end of January.

There’s a dearth of prescription weight-loss drugs, particularly since Abbott recently yanked Meridia from U.S. shelves at the FDA’s behest. The agency worried about Meridia’s heart risks, particularly given the “very modest weight loss” it provided.

So, Health Bloggers, with one experimental drug rejected by the FDA, one with a “no” vote from the advisory panel and another still awaiting its turn at bat, what are the odds of a new weight-loss drug approval in the next several months?

Update: This post has been updated to reflect that the FDA is requesting data on the drug’s effectiveness in diabetic patients.

by Katherine Hobson at http://blogs.wsj.com/health/2010/10/25/fda-says-no-at-least-for-now-to-arenas-weight-loss-pill/